A RANDOMIZED, DOUBLE-BLIND, VEHICLE-CONTROLLED, PARALLEL-GROUP TRIAL TO ASSESS THE EFFICACY, SAFETY AND TOLERABILITY OF P-3073 FOR TOPICAL TREATMENT OF NAIL PSORIASIS

Polichem S.A.0 个研究点目标入组 330 人开始时间: 2015年8月18日最近更新: 2018年2月19日

研究概览

暂无简介。

•- Written informed consent before starting any study related procedures.
•- Patients aged 18 to 80 years old of any race.
•- Males or females.
•- Patients with mild to moderate psoriastic fingernail(s) defined as fingernail/s with matrix psoriasis NAPSI score and/or bed psoriasis NAPSI score = 1 and = 3 at baseline.
•- In case of skin involvement, patients with established clinical diagnosis of mild-to-moderate psoriasis (BSA involvement = 8% or PASI = 10)
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 230
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 100

•- Woman who is pregnant, nursing an infant, or planning a pregnancy during the study period.
•- Use of any systemic treatment for psoriasis and/or nail psoriasis during the last six months before the screening visit.
•- Use of any topical treatment for nail psoriasis on fingernail during the last six months before the screening visit
•- Use of photochemotherapy or other forms of radiotherapy during the last four weeks before the screening visit.
•- Positive mycology findings
•- Systemic use of immunosuppressives, chemotherapy and corticosteroids during last three months before the screening visit.
•- Consumption of oral Vitamin D or its analogues during the last three months (calcipotriol topical use for plaque psoriasis is allowed).
•- History of hypercalcaemia or hypercalciuria.
•- HIV infection or any other immunodeficiency.
•- Alcohol or substance abuse.
•- Patients with history of allergic reactions to calcipotriol or its excipients.

发起方

Polichem S.A.